Multiple Areas of Pain (MAP)

Chronic Pain Clinical Trial

— MAP  

Official title:

Multiple Areas of Pain (MAP): Epidemiology of Multisite Pain in the Chronic Pain Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583894
• Other study ID #: A7003
• Secondary ID: CDM00044807
• Status: Completed
• Start date: June 2012
• Est. completion date: March 2014

Study information

• Verified date: November 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will collect pain-related information from chronic pain patients to gain an understanding of the prevalence of multi-site pain, and how it affects health outcomes like function, quality of life, depression, and anxiety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 828
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• Chronic pain of the trunk and/or limbs lasting at least 6 months

• Overall pain intensity of at least 5 on a 0 to 10 scale

• Subject is able to independently complete all assessments in English

• 18 years of age or older

• Subject signs an Institutional Review Board-approved informed consent form provided in English

Key Exclusion Criteria:

• Currently implanted with an active implantable medical device to treat pain

• Currently exhibits any characteristic that renders the subject ineligible for current or future treatment with spinal cord stimulation for chronic pain of the trunk and/or limbs

• Subject has undergone an interventional pain procedure less than 1 month prior to the study

Related Conditions & MeSH terms

• Chronic Pain

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Millennium Pain Center	Bloomington	Illinois
United States	Midwest Pain Center	Chesterfield	Missouri
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Global Scientific Innovations - Advanced Pain Care Clinic	Evansville	Indiana
United States	Houston Pain Associates	Houston	Texas
United States	UCSD Medical Center - Jacobs Medical Center	La Jolla	California
United States	Neurovations	Napa	California
United States	Comprehensive Pain & Rehabilitation	Pascagoula	Mississippi
United States	Channel Research	Pawleys Island	South Carolina
United States	Nexus Pain Care	Provo	Utah
United States	Integrated Pain Specialists of Southern California	San Diego	California
United States	Sheridan Clinical Research	Sunrise	Florida
United States	The Center for Clinical Research, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multi-site Pain Index	Multiple Site Pain Index (MSPI) was developed by collating multiple pain descriptors into a single index. Pain descriptors used for developing this index were percent body area in pain, number of painful areas, span of painful areas, and Regional Pain Ratings (RPRs) which includes data on pain severity and pain continuity for 47 body regions.; MSPI score ranged from 0 to 1; 0 representing no pain and 1 representing extreme continuous pain over entire body, except the head and face regions.	single-visit